Helium 4 Optically Pumped Magnetometers : a New Generation of Sensors for High Speed Functional Brain Imaging

NCT ID: NCT04615637

Last Updated: 2021-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2023-07-01

Brief Summary

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Our goal is to perform a first evaluation of the capabilities of a new generation of non-invasive magnetoencephalography sensors (OPM He4) to record brain magnetic activities. The investigator will record 1) normal subjects stimulated with visual, auditory, somesthesic and motor stimuli and 2) epileptic patient. The investigator will compare the signal to noise ratio of the normal or pathological activities between classical MEG sensors and our OPM He4 prototype.

Detailed Description

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Conditions

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Normal Subject Patient With Pharmaco-resistant Epilepsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Sensors

All subjects will follow the same experimental procedure: a recording using classical MEG followed by a recording in the same condition with the OPM He4 prototype.

Group Type EXPERIMENTAL

MEG recordings

Intervention Type DEVICE

1. Classical MEG recordings (patient at rest, normal subjects stimulated with visual, motor, somesthesic and auditory stimuli).
2. MEG recordings with our OPM He4 prototype (patient at rest, normal subjects stimulated with visual, motor, somesthesic and auditory stimuli).

Interventions

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MEG recordings

1. Classical MEG recordings (patient at rest, normal subjects stimulated with visual, motor, somesthesic and auditory stimuli).
2. MEG recordings with our OPM He4 prototype (patient at rest, normal subjects stimulated with visual, motor, somesthesic and auditory stimuli).

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Volunteers:

* Age 18+
* Right handed
* Medical insurance
* Strongly motivated to participate to the study
* Signed informed consent for the study
* No previous neurology or psychiatric pathologies
* No major cognitive deficit and able to understand the instructions

Patients:

* Age 18+
* Right handed
* Medical insurance
* Strongly motivated to participate to the study
* Signed informed consent for the study
* No previous neurology or psychiatric pathologies (except epilepsy)
* Epilepsy evolving during at least two years
* No major cognitive deficit and able to understand the instructions

Exclusion Criteria

Volunteers:

* Age \< 18 years or \> 60

* previous neurology or psychiatric pathologies
* Child bearing women
* Subject having one of the following mettalic parts :

* (pacemaker, implentable pump, neurosimulator, chochlear implant, auditory prothesis, mettalic prothesis, intracerebral clip, implantable defibrilator, any mettalic parts in the brain or upper part of the body, ventriculoperitoneal valve)
* Claustrophobia Woman with a positive pregnancy test during the inclusion.

Patients:

Age \< 18 years or \> 60

* previous neurology or psychiatric pathologies except epilepsy
* Child bearing women
* Subject having one of the following mettalic parts :

* (pacemaker, implentable pump, neurosimulator, chochlear implant, auditory prothesis, mettalic prothesis, intracerebral clip, implantable defibrilator, any mettalic parts in the brain or upper part of the body, ventriculoperitoneal valve)
* Claustrophobia Woman with a positive pregnancy test during the inclusion.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julien JUNG, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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Hospices Civils de Lyon

Bron, , France

Site Status

Countries

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France

Central Contacts

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Julien JUNG, MD

Role: CONTACT

04.72.35.79.00

Denis SCHWARTZ, MD

Role: CONTACT

04.72.13.89.61

Facility Contacts

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Julien JUNG, MD

Role: primary

04 72 35 79 00

Other Identifiers

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2020-A00634-35

Identifier Type: REGISTRY

Identifier Source: secondary_id

69HCL20_0191

Identifier Type: -

Identifier Source: org_study_id

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